This study is designed to test if a sequential protease-inhibitor (PI) - / nevirapine (NVP) -based regimen is effective for the treatment of HIV-infected children when previous NVP exposure has occurred as part of programs to prevent mother-to-child transmission (pMTCT).

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Virologic suppression at 6 months after randomization

Secondary Outcome Measures:

To compare the time to virologic failure up to 18 months post randomization

to examine the associations between detection of drug resistance mutation and virologic response to treatment

to compare the toxicity profiles and adherence in the two groups

to describe the emergence of genotypic resistance in the two groups

Estimated Enrollment:

250

Study Start Date:

April 2005

Estimated Study Completion Date:

September 2010

Detailed Description:

The wide use of NVP in pMTCT-prophylaxis may result in resistance to NNRTI and concomitantly limits the use of these drugs for the treatment of HIV-infected children. To avoid restricting treatment options for children, it is desirable to preserve NVP for both pMTCT and first line treatment. This study will therefore test whether resistance-caused treatment failures of HIV-infected and previously NVP-exposed children can be avoided if the NVP treatment is preceded by an initial PI-based regimen.

Comparison: HIV-infected children less than 24 months of age, exposed to any pMTCT regimen that included NVP and who achieve and maintain viral suppression for at least 3 months with a PI-based regimen will be randomized to one of the two groups: (1) to continue on PI-containing regimen or (2) to be switched off the PI-containing regimen onto the NVP-containing regimen. The study outcome will be proportions in the two groups who have complete virologic suppression at 6 months after randomization.

Eligibility

Ages Eligible for Study:

up to 24 Months (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

NVP-exposure as part of pMTCT-prophylaxis around delivery

HIV-positive

Eligible for treatment

Plans to stay in the area for the next 6 months

Exclusion Criteria:

Already on anti-retroviral treatment

History of toxicity to perinatal NVP

Grade 3 or greater elevation of liver function tests

Being treated for a severe acute opportunistic infection or tumor

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117728

Locations

South Africa

Coronation Hospital

Johannesburg, South Africa

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)